Monitoring the safety of tofacitinib in ulcerative colitis patients
An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
This study is trying to see how safe the medication tofacitinib is for adults with moderate to severe ulcerative colitis by comparing its side effects to those of other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Academic / other |
| Drugs / interventions | tofacitinib |
| Locations | 5 sites (Bonheiden and 4 other locations) |
| Trial ID | NCT06469424 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the incidence rates of various safety events in adult patients with moderately to severely active ulcerative colitis who are treated with tofacitinib. It will compare these rates to those in patients receiving other approved medications for ulcerative colitis. The study will utilize data from the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union, focusing on a cohort of patients with a minimum follow-up duration of 12 months. The research will specifically look at risks such as malignancy, venous thromboembolic events, and other serious health complications associated with tofacitinib treatment.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older with a diagnosis of ulcerative colitis who are enrolled in the UR-CARE registry.
Not a fit: Patients with a history of Crohn's disease or unspecified inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of tofacitinib, helping to inform treatment decisions for ulcerative colitis patients.
How similar studies have performed: Previous studies have indicated the need for ongoing safety evaluations of tofacitinib, suggesting that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged ≥18 years, * With Ulcerative colitis diagnosis per ECCO guidelines, * Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date, * With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest. Exclusion Criteria: * Patients not meeting the inclusion criteria * Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \[i.e. date of first prescription for tofacitinib\].
Where this trial is running
Bonheiden and 4 other locations
- Imelda General Hospital — Bonheiden, Belgium (Recruiting)
- AZ Delta vzw — Roeselare, Belgium (Recruiting)
- Acibadem City Clinic Tokuda University Hospital — Sofia, Bulgaria (Recruiting)
- General Hospital of Athens "Evangelismos" — Ellinikó, Attica, Greece (Recruiting)
- Lithuanian University of Life Sciences — Kaunas, Lithuania (Not_yet_recruiting)
Study contacts
- Principal investigator: Manuel MD Barreiro, PhD — Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Study coordinator: Eva María Rodríguez
- Email: secretariacientifica1@geteccu.org
- Phone: +34 691 08 42 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.